2. Outcomes table.
Study | Comparison type* | Interventions (dressings) | Length of follow‐up | Proportion healed | Time to healing | Adverse events | Proportion with pain | Proportion with infection |
Quality of life mean (SD) |
Resource use |
Andriessen 2009 | 2a and 2b | Group 1: PMM + foam (n = 4); Group 2: foam (n = 4) Group 3: basic wound contact (n = 4) |
4 weeks | Not reported | Not reported | Group 1: 0/4 Group 2: 0/4 Group 3: 0/4 | Group 1: 0/4 Group 2: 0/4 Group 3: 4/4 Peto OR for 1 vs 3: 0.03 (95% CI 0.00 to 0.40) |
Not reported | Not reported | |
Cullen 2012 | 3 | Group 1: PMM1 (n = 32); Group 2: PMM2 (n = 32) |
4 weeks | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | |
Hanft 2006 | 2a | Group 1: PMM‐silver + hydrocolloid (n = 22); Group 2: hydrocolloid (n = 27) |
4 weeks and 12 weeks |
4 weeks Group 1: 5/22 Group 2: 3/27 RR 2.05 (95% CI 0.55 ‐ 7.63) 12 weeks Group 1: 14/22 Group 2: 16/27 |
Not reported | Not reported | No results reported (though in protocol) | No results reported (though in protocol) | No results reported (though in protocol) | |
Humbert 2013 | 2c | Group 1: PMM (n = 34); Group 2: hydrogel (n = 41) |
2 weeks | Not reported | Not reported | Group 1: 15/34 Group 2: 18/41 |
Group 1: 7/32 Group 2: 0/39 |
Group 1: 0/32 Group 2: 2/39 |
Not reported | |
Lanzara 2008 | 2a | Group 1: PMM‐silver + foam (n = 15); Group 2: foam (n = 15) |
12 weeks | Group 1: 11/15 Group 2: 7/15 |
Not reported | Not reported | Not reported | Group 1: 4/15 Group 2: 5/15 |
Not reported | |
Manizate 2012 | 2c | Group 1: PMM‐silver (n = 10); Group 2: hydrocolloid + silver (n = 10) |
8 weeks | Group 1: 3/10 Group 2: 5/10 |
Not reported | Not reported | Not reported | Group 1: 0/10 Group 2: 0/10 |
Not reported | |
Meaume 2012 | 2d | Group 1: PMM‐foam (n = 93); Group 2: foam (n = 94) |
8 weeks | Group 1: 6/93 Group 2: 7/94 |
Not reported | Group 1: 29/89 Group 2: 27/88 |
Group 1: 1/89 Group 2: 1/88 | Group 1: 7/89 Group 2: 6/88 |
EQ‐5D: Pain/discomfort: Group 1: mean 1.53 (SD 0.53) n = 89 Group 2: 1.74 (0.65) n = 88 MD: ‐0.21 (95% CI ‐0.38 to ‐0.04) Anxiety/depression: 1.35 (0.53) and 1.54 (0.60) MD: ‐0.19 (95% CI ‐0.36 to ‐0.02) numbers analysed assumed |
Mean total treatment costs over 8 weeks (Germany): Group 1: EUR 557.51 Group 2: EUR 526.19 Cost effectiveness analysis was based on number with at least 40% wound area reduction and so are not reported here |
Petkov 1997 | 2d | Group 1: PMM‐alginate Group 2: alginate |
6 months |
6 months: Group 1: 34/50 Group 2: 32/50 RR: 1.06 (95% CI 0.80 to 1.41) |
Graph of cumulative number of healed ulcers. HR calculated (Tierney 2007): 1.21 (95% CI 0.75 to 1.97), assuming no censoring | Not reported | Not reported | Not reported | QoL/Resources not reported. ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐ Number healed at other times (from graph); 50 randomised per group): 1 month: 2 and 0 2 months: 12 and 8 3 months: 26 and 20 4 months: 29 and 22 5 months: 34 and 31 |
|
Romanelli 2015 | 2a | Group 1: PMM + basic wound contact dressing + alginate (n = 20); Group 2: alginate (n = 20) |
12 weeks | Group 1: 6/20 Group 2: 5/20 | Not reported | Group 1: 0/20 Group 2: 0/20 |
Group 1: 0/20 Group 2: 0/20 | Not reported | Not reported | |
Schmutz 2008 | 3 | Group 1: PMM1 (n = 57); Group 2: PMM2 (n = 60) |
12 weeks | Group 1: 10/57 Group 2: 8/60 RR: 1.32 (95% CI 0.56 to 3.10) |
Not reported | Group 1: 14/46 Group 2: 23/49 RR: 0.65 (95% CI 0.38 to 1.10) |
Group 1: 4/40 Group 2: 12/36 |
Group 1: 1/40 Group 2: 6/36 |
Not reported | |
Smeets 2008 | 2a | Group 1: PMM + hydrocolloid (n = 17); Group 2: hydrocolloid (n = 10) |
12 weeks | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | |
Vin 2002 | 1 | Group 1: PMM + basic wound contact dressing (n = 37); Group 2: basic wound contact dressing (n = 36) |
12 weeks | Group 1: 18/37 Group 2: 12/36 |
Not reported | Group 1: 5/30 Group 2: 5/29 |
Severe pain: Group 1: 6/27 Group 2: 3/24 Constant pain: Group 1: 7/27 Group 2: 4/24 RR: 1.56 (95% CI 0.52 to 4.67) |
Group 1: 0/27 Group 2: 5/24 |
Saline vials per treatment:
Group 1: mean 1.06 (SD 0.78)
Group 2: mean 1.27 (SD 0.78) MD: ‐0.21 (95% CI ‐0.31 to ‐0.11) Number of gauzes: Group 1: 3.8 (2.5) Group 2: 3.7 (2.2) MD: 0.10 (95% CI ‐0.17 to 0.37) (SD 201) seconds MD: ‐40.0 (95% CI ‐128.9 to 48.9) |
* Comparison types:
1. PMM dressing regimen versus basic wound contact dressing regimen
2a. PMM dressing regimen versus advanced dressing regimen with the secondary dressing in the experimental group the same as the primary dressing in the control group
2b. PMM dressing regimen versus advanced dressing regimen with the secondary dressing in the experimental group being similar but different from the primary dressing in the control group
2c. PMM dressing regimen versus advanced dressing regimen with the same secondary dressings in both groups or no secondary dressings or secondary dressings only in the control group
2d. PMM dressing regimen versus advanced dressing regimen: PMM/advanced combination dressing versus advanced dressing
3. PMM dressing 1 versus PMM dressing 2